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History of Changes for Study: NCT00526253
To Assess Safety and Efficacy of Myoblast Implantation Into Myocardium Post Myocardial Infarction (MARVEL)
Latest version (submitted July 20, 2017) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 September 6, 2007 None (earliest Version on record)
2 October 2, 2008 Recruitment Status, Study Status, Eligibility, Conditions, Contacts/Locations, Arms and Interventions, Study Description, Oversight and Sponsor/Collaborators
3 October 6, 2008 Contacts/Locations and Study Status
4 June 17, 2009 Contacts/Locations and Study Status
5 October 26, 2010 Recruitment Status, Study Status, Contacts/Locations and Study Design
6 January 4, 2013 Study Status
7 January 26, 2015 Study Status
8 January 30, 2017 Study Status
9 July 20, 2017 Recruitment Status and Study Status
Comparison Format:

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Study NCT00526253
Submitted Date:  September 6, 2007 (v1)

Open or close this module Study Identification
Unique Protocol ID: BMI-WW-02-003
Brief Title: To Assess Safety and Efficacy of Myoblast Implantation Into Myocardium Post Myocardial Infarction (MARVEL)
Official Title: A Multicenter Study to Assess the Safety and Cardiovascular Effects of Myocell™ Implantation by a Catheter Delivery System in Congestive Heart Failure Patients Post Myocardial Infarction(s)
Secondary IDs:
Open or close this module Study Status
Record Verification: September 2007
Overall Status: Not yet recruiting
Study Start: November 2007
Primary Completion:
Study Completion:
First Submitted: September 6, 2007
First Submitted that
Met QC Criteria:
September 6, 2007
First Posted: September 10, 2007 [Estimate]
Last Update Submitted that
Met QC Criteria:
September 6, 2007
Last Update Posted: September 10, 2007 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Bioheart, Inc.
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: This study injects a person's own stem cells into heart muscle tissue after a person has one or more heart attacks. The purpose of the study is whether the stem cells will improve a patient's heart performance.
Detailed Description:
Open or close this module Conditions
Conditions: Cardiac Heart Failure
Keywords: Cardiac Heart Failure
CHF
Heart Disease
Heart Attack
Stem Cell
Myoblast
Bioheart
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2/Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 3
Masking: Triple (Participant, Care Provider, Investigator)
Allocation: Randomized
Enrollment: 390 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Active Comparator: Low Dose
Patient will undergo biopsy. Skeletal myoblasts will be cultured in growth media.
Biological: MyoCell
Patient will receive injections of cultured, expanded skeletal myoblasts into the myocardium at a dose of 400 x 106 cells.
Active Comparator: High Dose
Patient will undergo biopsy. Skeletal myoblasts will be cultured in growth media.
Biological: MyoCell
Patient will receive injections of cultured, expanded skeletal myoblasts into the myocardium at a dose of 800 x 106 cells.
Placebo Comparator: Control
Patient will undergo biopsy of muscle tissue and biopsy tissue will be sent to lab.
Procedure: Hypothermosol
After the cell culture period of time has passed, patient's myocardium will be injected with the transport media alone. Patient will not receive any cultured myoblasts during these injections.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 6-minute walk test
[ Time Frame: 6 months ]

2. Quality of Life Questionnaire
[ Time Frame: 6 months ]

Secondary Outcome Measures:
1. Hospitalization occurrences
[ Time Frame: 12 months ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 80 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers:
Criteria:

Inclusion Criteria:

  1. Chronic CHF, New York Heart Association (NYHA) Class II-III, stable and on optimal medical therapy for >60 days;
  2. Age greater than or equal to 18 years but less than or equal to 80 years;
  3. Left ventricular ejection fraction (LVEF) at screening of less than 35% (by multiple gated acquisition scan [MUGA]) as determined by a central reading;
  4. Need or feasibility for revascularization has been ruled out by previous coronary angiogram re-assessed using Dobutamine Stress Echocardiography (DSE) at screening;
  5. Defined region of myocardial dysfunction related to previous MI involving the anterior, lateral, posterior, or inferior walls including the apical septum (excluding the basal septum) assessed by a large area of akinesia in the left ventricle (using DSE at screening).

Exclusion Criteria:

  1. Non-pregnant women who are not postmenopausal, surgically sterile or not practicing an acceptable method of contraception. A female patient of child bearing potential, with a positive serum or urine pregnancy test at screening visit #1. Males refusing to exercise a reliable form of contraception;
  2. Brain natriuretic peptide (BNP) <250 pg/mL (picograms per milliliter);
  3. Myocardial wall thickness of <6 mm (millimeters) in the akinetic myocardial region to be injected (using DSE at screening)
  4. Inability to undergo a surgical biopsy of the skeletal muscle for culture of myoblasts, including any significant myopathy;
  5. Not fitted, or fitted within less than 60 days prior to screening visit #1, with an implantable cardioverter defibrillator (ICD);
  6. Sustained ventricular tachycardia (VT), automatic implantable cardiodefibrillator (AICD) firing, or ventricular fibrillation (VF) within 90 days prior to screening visit #1;
  7. Inability to perform a 6 minute walk test due to physical limitations other than HF including:
    1. Severe peripheral vascular disease, including aortic aneurysms, leading to limited claudication;
    2. Severe pulmonary disease or chronic obstructive pulmonary disease (COPD) limiting exercise, dependence on chronic oral steroid therapy or previously requiring mechanical ventilation;
    3. Stroke or transient ischemic attack leading to limitations in lower extremities or occurring within 180 days prior to screening visit #1;
  8. MI, unstable angina or percutaneous coronary intervention (PCI) within 90 days prior to screening, or having undergone CABG surgery within 150 days prior to screening visit #1;
  9. Active myocarditis, constrictive pericarditis, restrictive, hypertrophic or congenital cardiomyopathy;
  10. Hemodynamically significant severe primary valvular heart disease, unless corrected by a properly functional prosthetic valve, or prior aortic valve replacement;
  11. Systolic blood pressure (supine) ≤90 mmHg;
  12. Severe uncontrolled HF including any evidence of severe fluid overload such as peripheral edema >+2 or rales ≥1/3 the lungs' height, need for intravenous therapy for HF within 60 days of screening visit #1 or hospitalization for HF within 90 days of screening visit #1;
  13. Expected to receive or received a cardiac transplant, surgical remodeling procedure, left ventricular assist device or cardiomyoplasty;
  14. Six-minute walk test (6MWT) of >400 meters or Minnesota Living With Heart Failure (MLWHF) score of <20;
  15. Third degree atrioventricular (AV) block or symptomatic bradyarrhythmias, unless these rhythms have been treated with a properly functioning permanent pacemaker, a resting heart rate <50 beats per minute (bpm) or >125 bpm or supraventricular arrhythmia requiring therapy within 60 days of screening, other than atrial fibrillation;
  16. Hematocrit (HCT) concentration below 30%;
  17. Serum creatinine greater than 2.5 mg/dL (milligrams per deciliter) or end stage renal disease;
  18. Left ventricular mural thrombus;
  19. Known sensitivity to gentamicin sulfate; or severe adverse reaction to nonionic radiocontrast agents;
  20. Active infectious disease and/or known to have tested positive for human immunodeficiency virus (HIV), human t lymphotrophic virus (HTLV), hepatitis B virus (HBV), hepatitis C virus (HCV), cytomegalovirus (CMV); immunoglobulin M [IgM], and/or syphilis. If the panel includes antibodies to the HBV core antigen (HBV-cAg) and hepatitis B surface antigen (HBV-sAg), then an expert will be consulted as to patient's eligibility based on the patient's infectious status;
  21. Exposure to any previous experimental angiogenic therapy and/or myocardial laser therapy, or therapy with another investigational drug within 60 days of screening visit #1 or enrollment in any concurrent study that may confound the results of this study;
  22. Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or in the opinion of the investigator are not suitable to participate;
  23. Any illness other than CHF which might reduce life expectancy to less than 1 year from screening visit #1; and
  24. Unwilling and/or not able to give written informed consent.
Open or close this module Contacts/Locations
Central Contact Person: Doug Owens, RN, MPH, CCRA
Telephone: 954-835-1500
Email: dowens@bioheartinc.com
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links: Description: Bioheart Inc. website
Available IPD/Information:

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